No, Class I medical device registration with ANVISA in Brazil does not require annual reviews. However, once registered, the device must be maintained in compliance with ANVISA's regulations and subject to post-market surveillance.

Key Points Regarding Class I Medical Device Registration and Ongoing Compliance:

1. No Annual Review:

   • Unlike some higher-risk medical devices, Class I devices do not require annual renewal or periodic reviews once the registration has been granted.
   • Once the device is registered with ANVISA, the registration remains valid as long as the manufacturer continues to meet regulatory requirements.

2. Post-Market Surveillance:

   • Although there's no annual review, the manufacturer or importer is required to monitor the device's performance in the market and report any adverse events or safety concerns to ANVISA.
   • Any incidents that could affect the safety and efficacy of the device must be communicated promptly to ANVISA for further investigation.

3. Amendments:

   • If there are changes to the device (such as modifications in labeling, manufacturing processes, or intended use), an amendment to the registration must be submitted to ANVISA.
   • Changes that could impact the safety or regulatory classification of the device may require a new evaluation by ANVISA.

4. Annual Fees:

   • ANVISA charges an annual fee for maintaining the registration of medical devices, but this fee is not related to a regular review of the device itself. The fee is more about keeping the registration active and ensuring compliance with any post-market requirements.

5. Re-Registration:

   • If the device is subject to a major update or a change in its regulatory classification, it might require re-registration. However, this does not automatically happen on an annual basis for Class I devices.

In Conclusion:

While Class I medical devices in Brazil do not require annual reviews with ANVISA, manufacturers are responsible for ensuring that the device remains in compliance with regulatory standards and must inform ANVISA of any changes or issues related to the product. Post-market surveillance is essential to maintain the device’s safety and efficacy over time.

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